2025 <Special News Flash>｜News Letter

Grand Panel Decides that Invention of Composition which is Prepared from Blood and which is Intended to be Returned into Body is Industrially Applicable, and that Preparation of Breast Augmentation Composition by Doctor Constitutes Infringement.

Tokai Ika Co., Ltd. v. Y (Individual, Medical Doctor), Case No. 2025 (Ne) 10040 (Decision rendered on March 19, 2025)

The Grand Panel¹⁾ of the IPHC (Chief Judge, Tomonari HONDA) rendered a decision that the invention of a composition which was prepared by using an ingredient (blood) extracted from a human body as a raw material and which was eventually intended to be returned or administered to the body was industrially applicable; and that the preparation of such a composition for breast augmentation by a medical doctor did not satisfy the exemption provision for the preparation of medicine by physicians or dentists (Art. 69 (3) of the Patent Act²⁾), thus it constituted the infringement.

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The Patentee, Tokai Ika (TI) obtained a patent relating to a breast augmentation composition comprising (1) an autologous plasma, (2) a basic fibroblast growth factor (b-FGF) and (3) a fat emulsion in 2013.

On the basis of the above patent, TI filed a patent infringement suit against Y (individual, medical doctor) with Tokyo District Court in 2022. Tokyo District Court dismissed the TI’s claim on March 24, 2023 on the grounds that it could not be acknowledged that Y prepared a medicament simultaneously containing (1) to (3) to administer it to a person who was intended to receive the treatment.

Against the Tokyo District Court’s decision, the losing party, TI filed an appeal with the IPHC in 2023.
During the court proceedings, the IPHC solicited opinions from the public in June 2024 by utilizing the "third-party opinion solicitation" system, which was introduced with the amendment of the Patent Act in 2021 by reference to the amicus brief system in the US. This was the second time such a solicitation of opinions had been conducted.
Thereafter, the IPHC decided to hear this case before the Grand Panel in December, 2024.

The Grand Panel of the IPHC decided as follows:

(1) Fact Finding Regarding Y’s act
Taking into consideration the notebooks prepared by Y for the breast augmentation surgery, the documents provided to the persons who were intended to receive the treatment, and the advertisements, it can be acknowledged that Y prepared the claimed medicament simultaneously containing the above-mentioned ingredients (1) to (3) and administered it to the persons who were intended to receive the treatment.

(2) Industrial Applicability³⁾
The amendment of the Patent Act in 1975 made it clear that medical inventions could be patented, thus it is difficult to interpret that a "product invention" is essentially a "method invention" which is targeted at medical procedures, accordingly does not constitute an "invention that is industrially applicable" on the grounds that the product invention is intended to be administered to the human body.
In addition, the act of manufacturing medicines, etc. using raw materials extracted from humans is not necessarily performed by physicians, and the development of these technologies has been greatly contributed to by not only physicians but also by research and development in the pharmaceutical industry and other industries, and these technologies can be used to maintain and restore human life and health, so it is necessary to recognize patent protection in order to promote the development of technology.
Therefore, a product invention that is intended to be returned to the human body using raw materials extracted from the human body cannot be said to be substantially a "method invention", or not to be an "industrially applicable invention" due to the fact that it is deemed as medical act in view of a series of actions.

(3) Exemption Provision for Preparing Medicine
It is understood based on the description of the specification, etc. that the claimed composition is used for breast augmentation, and that its purpose is primarily aesthetic. Furthermore, even in light of current social conventions, the claimed composition cannot be recognized as "a product used for the diagnosis, therapy, treatment or prevention of human diseases."
Therefore, it is clear that the claimed invention does not constitute a "medicinal invention to be manufactured by mixing two or more medicines," thus there is no need to consider whether Y's act constitutes an “act of preparation of a medicine as per a physician's or dentist's prescription”; and accordingly, the Y's defense that the patent right has no effect against the accused acts pursuant to Art. 69 (3) of the Patent Act is without merit.

(4) Amount of Damages
Y ordered nurses and other staff at the clinic he operated to extract blood samples from persons who were intended to receive the treatment, manufactured the compositions within the scope of the claim, and administered the compositions to the persons in breast augmentation surgery, thereby earning sales of at least 170 million yen during May 27, 2020 and July 24, 2021.
Taking all circumstances into consideration, the amount of damages calculated pursuant to Art. 102 (3) of the Patent Act should be 8% of the above-mentioned sales.

Conclusively, the IPHC overturned the decision rendered by the 1st instance, i.e. the Tokyo District Court, and ordered Y to pay approximately 15 million yen (100 thousand dollars) in damages.

The losing party is entitled to bring the case to the Supreme Court within 14 days after the dispatch date of the decision, thus the decision is NOT final and binding as of end of March, 2025.

¹⁾ Grand Panel: The Grand Panel is convened to hear cases where it is necessary to virtually unify court decisions, or cases involving important issues, which is somewhat similar to en banc in CAFC of the U.S.A. Since the founding of the IPHC in 2005, 15 cases including the above case have been heard by the Grand Panel.

²⁾ Article 69 (3) of Patent Act
A patent right for a medical invention (medicine meaning a product used in the diagnosis, therapy, treatment or prevention of a human diseases; hereinafter the same applies in this paragraph) that is to be manufactured by two or more medicines being mixed together or for the invention of a process by which a medicine is manufactured by two or more medicines being mixed together has no effect against the act of preparation of a medicine as per a physician's or dentist's prescription nor against medicine prepared as per a physicians or a dentist's prescription.

³⁾ The Body of Article 29 (1) of Patent Act
Any person who has made an invention which is industrially applicable may obtain a patent for that invention, except for the following inventions:

K&P’s Comments This Grand Panel decision affirms the JPO’s practice that the invention of composition or product of which raw material(s) is extracted from human body and which is intended to be returned or administered to the body is industrially applicable; and rules that the exemption provision for preparing medicine is not applied to products or methods for cosmetic purpose, which can infringe a patent.